Health Condition 1: U071- COVID 19 virus identified
Conditions
Interventions
Intervention1: ProLectin M: ProLectin M is an orally administered polysaccharide. Polysaccharides competitively bind to the Nterminal
tail of human galectin-3 through a proline isomerization [10]. Gal
Sponsors
Pharmalectin Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or Female patient of >=â??18 years of age, willing and able to provide written informed consent for participation in the study and ready to comply with the study procedures and schedule. 2. Patient having a positive diagnosis for the presence of SARS-CoV- 2, obtained from a recently performed rRT-PCR ( the following: i. Ct value ii. Hospitalized for having classical (CDC defined) symptoms of COVID-19 (onset iii. High risk category of COVID-19: blood group type A-positive type 2 diabetes, or other chronic disease known to have higher morbidity risk with SARS-CoV-2 infection. 3. Patient has the ability to take oral medication and be willing to adhere to the trial protocol regimen of repeated swab collections and frequent follow-up for 10 days. 4. Females of childbearing potential who has been using highly effective contraception for at least 1 month prior to screening and agree continue using it during the study participation/enrolment, confirmed through negative pregnancy test
Exclusion criteria
Exclusion criteria: 1. Oxygen Saturation levels (SpO2) 2. Female patients who are pregnant or breastfeeding. 3. Patients with any active malignancy or undergoing active chemotherapy. 4. Patients who are currently receiving or have received any investigational treatment for COVID-19 within 30 days prior to screening. 5. In the opinion of the Investigator, the participation of the patient in the study is not in the patientâ??s best interest, or the patient has any medical condition that does not allow the study protocol to be followed safely. 6. Patients with known allergies to any of the components used in the formulation of the interventions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to non-detection of viral shedding in outpatient swab, detecting quantitative SARS-CoV-2 in nasopharynx [Time frame: 3, 5, 7, 10 days] Co-primary Endpoint 2: Proportion of patients who show improvement will be compared between the two groupsTimepoint: [Time frame: 3, 5, 7, 10 days] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Among patients admitted in hospital / healthcare facility / makeshift camp / isolated inside home [Time frame: 3, 5, 7, 10 days] 2. Duration of hospitalization [Time frame: 10 days] 3. Rate of mortality / Serious adverse events [Time frame: 10 days] 4. Rate of adverse eventsTimepoint: Time frame: from time of signing informed consent till day 10 | — |
Countries
India
Contacts
Public ContactSunita C
Samahitha Research Solutions
Outcome results
None listed